The PAIN (Pelvic Area Injection for Numbness) Study

NCT05972681 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-14825
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.

Conditions

Vaginal Laceration During Delivery

Outcome Measures

Primary Outcomes (5)

• Time to first analgesic

  Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable.

  Up to 24 hours after perineal laceration

• Maternal Satisfaction

  Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)

  24 hours after perineal laceration

• Maternal Satisfaction

  Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)

  48 hours after perineal laceration

• Maternal Satisfaction

  Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)

  7 days after perineal laceration

• Pain score after injection at perineal laceration

  Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where "no pain" is on the left end (0 cm) of the scale and the "worst pain" is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions

  Immediately and 24 hours after perineal laceration

Study Arms (2)

Local Anesthesia arm

EXPERIMENTAL

Bupivicaine and Epinephrine

Drug: Bupivacaine; Drug: Epinephrine

Normal saline sham arm

SHAM COMPARATOR

Other: Sham normal saline arm

Interventions

Bupivacaine DRUG

10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.

Local Anesthesia arm

Epinephrine DRUG

Epinephrine (1:200,000) injected to the vaginal laceration site.

Local Anesthesia arm

Sham normal saline arm OTHER

10 milliliter (ml) of normal saline injected to the vaginal laceration site.

Normal saline sham arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years old
• Healthy with a singleton pregnancy
• English or Spanish speaking
• Ongoing functioning epidural throughout the laceration repair
• Multiparous or nulliparous
• Ability to consent for themselves

You may not qualify if:

• Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
• Vaginal delivery was complicated by a postpartum hemorrhage
• Have multiple gestations
• Complaints of non-functional epidural
• Allergic to bupivacaine and/or epinephrine
• Epidural was a combined spinal-epidural (CSE)
• Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) \< 3 hours from the perineal repair
• Experienced extreme pain at time of study consent (pain scale score \> 3 on 0-10 scale)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (7)

• Goh R, Goh D, Ellepola H. Perineal tears - A review. Aust J Gen Pract. 2018 Jan-Feb;47(1-2):35-38. doi: 10.31128/AFP-09-17-4333.

  PMID: 29429318 BACKGROUND

• Butwick AJ, Bentley J, Wong CA, Snowden JM, Sun E, Guo N. United States State-Level Variation in the Use of Neuraxial Analgesia During Labor for Pregnant Women. JAMA Netw Open. 2018 Dec 7;1(8):e186567. doi: 10.1001/jamanetworkopen.2018.6567.

  PMID: 30646335 BACKGROUND

• Dengler KL, Simpson KJ, Strauchon CJ, Shaddeau AK, Brooks DI, Gruber DD. A randomized controlled trial of liposomal bupivacaine for pain following obstetrical laceration. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100115. doi: 10.1016/j.ajogmf.2020.100115. Epub 2020 Apr 15.

  PMID: 33345866 BACKGROUND

• Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management: ACOG Clinical Consensus No. 1. Obstet Gynecol. 2021 Sep 1;138(3):507-517. doi: 10.1097/AOG.0000000000004517.

  PMID: 34412076 BACKGROUND

• Schinkel N, Colbus L, Soltner C, Parot-Schinkel E, Naar L, Fournie A, Granry JC, Beydon L. Perineal infiltration with lidocaine 1%, ropivacaine 0.75%, or placebo for episiotomy repair in parturients who received epidural labor analgesia: a double-blind randomized study. Int J Obstet Anesth. 2010 Jul;19(3):293-7. doi: 10.1016/j.ijoa.2009.11.005. Epub 2010 Jun 2.

  PMID: 20627696 BACKGROUND

• Deshpande JP, Saundattikar GY. Lignocaine Versus Ropivacaine Infiltration for Postpartum Perineal Pain. Anesth Essays Res. 2017 Apr-Jun;11(2):300-303. doi: 10.4103/0259-1162.177191.

  PMID: 28663610 BACKGROUND

• Mahajan A, Derian A. Local Anesthetic Toxicity. StaPearls. Bookshelf ID: NBK499964. PMID: 29763139

  BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Fatima Estrada, MD, FACOG

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa M Yeung, MD

CONTACT

574-329-8771; ayeung@montefiore.org

Fatima Estrada, MD, FACOG

CONTACT

718-904-2767; festrada@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be blinded to the patient, the nurse carrying for the patient and providing the randomized, unlabeled syringe, the provider performing the perineal repair, the research team asking the maternal satisfaction questions, and the researcher analyzing the data. To assure blinding, the selection of the medication given, and the preparation of such medication will be performed by the labor and delivery anesthesia team. No one involved directly in the perineal laceration repair, or obtaining research information, nor the patient, will know what was injected. Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated. Urgent, immediate unblinding due to medical emergency may be authorized by the Investigator. When possible, the treatment assignment will be provided to the treating physician to maintain the blind for the Investigator and study staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 2, 2023
• Study Start: April 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)